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FDA NDA · NDA202343

JUVISYNC

Sponsor: MERCK SHARP DOHME

APPLICATION
NDA202343
TYPE
NDA
ORIGINAL APPROVAL
2011-10-07
LATEST ACTION
2014-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

JUVISYNC · ReferenceDiscontinued
SIMVASTATIN 20MG, SITAGLIPTIN PHOSPHATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
JUVISYNC · ReferenceDiscontinued
SIMVASTATIN 40MG, SITAGLIPTIN PHOSPHATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
JUVISYNC · ReferenceDiscontinued
SIMVASTATIN 10MG, SITAGLIPTIN PHOSPHATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
JUVISYNC · ReferenceDiscontinued
SIMVASTATIN 40MG, SITAGLIPTIN PHOSPHATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
JUVISYNC · ReferenceDiscontinued
SIMVASTATIN 10MG, SITAGLIPTIN PHOSPHATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
JUVISYNC · ReferenceDiscontinued
SIMVASTATIN 20MG, SITAGLIPTIN PHOSPHATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2014-02-24Labeling · Supplement 11 · standard — Label ↗AP
2013-11-08Manufacturing (CMC) · Supplement 9 · standardAP
2013-10-25Labeling · Supplement 8 · standard — Label ↗AP
2013-08-19Labeling · Supplement 10 · standard — Label ↗AP
2013-02-11Labeling · Supplement 6 · standard — Label ↗AP
2012-10-31Labeling · Supplement 7 · standard — Label ↗AP
2012-10-31Labeling · Supplement 5 · standard — Label ↗AP
2012-09-18Efficacy · Supplement 1 · standard — Label ↗AP
2012-09-18Labeling · Supplement 4 · standard — Letter ↗AP
2012-09-18Labeling · Supplement 2 · standard — Letter ↗AP
2011-10-07Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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